A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity

Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity

The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body.

The study compares three different doses of the study medicine in Chinese healthy men.

Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance.

NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.

We are testing the study medicine to make a medicine that can help people lose weight.

Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area.

The study will last for about 5 months. But participants participation will last about 2 months.

Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay.

At all visits, except the information visit, participant will have blood drawn along with other clinical examinations.

Participants will be asked about their health, medical history and habits including mental health.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: NNC0174 0833

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Key inclusion criteria

• Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening.
• Body weight between 60.0 and 110.0 kg (both inclusive) at screening.

Key exclusion criteria

• Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
• Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0174 0833 1.8 mg; Each participant will receive one single dose of NNC0174 0833	Drug: NNC0174 0833; Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)
Experimental: NNC0174 0833 0.9 mg; Each participant will receive one single dose of NNC0174 0833	Drug: NNC0174 0833; Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)
Experimental: NNC0174 0833 0.3 mg; Each participant will receive one single dose of NNC0174 0833	Drug: NNC0174 0833; Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose	measured in h·nmol/L	From pre-dose (Day 1) to Visit 7 (Day 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose	measured in h·nmol/L	From pre-dose (Day 1) to Visit 3 (Day 8)
Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma	measured in nmol/L	From pre-dose (Day 1) to Visit 7 (Day 36)
tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833	measured in hours	From pre-dose (Day 1) to Visit 7 (Day 36)
t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833	measured in hours	From pre-dose (Day 1) to Visit 7 (Day 36)
CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833	measured in L/h	From pre-dose (Day 1) to Visit 7 (Day 36)
Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase	measured in L	From pre-dose (Day 1) to Visit 7 (Day 36)
Change in body weight	measured in percentage	From pre-dose (Day 1) to Visit 7 (Day 36)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: NN9838-4615; U1111-1247-7538 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No